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510(k) Data Aggregation
K Number
K233386Device Name
Monik - Disposable Endoscopic Trocar
Manufacturer
M/s. Meril Endo Surgery Private Limited.
Date Cleared
2024-05-24
(235 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description
The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
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K Number
K232246Device Name
1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2024-04-25
(272 days)
Product Code
NEW, GAM
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
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K Number
K200452Device Name
Meril-Bonewax
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2023-03-27
(1127 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
Device Description
MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.
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K Number
K200320Device Name
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2021-02-05
(364 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mirus™ Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.
Device Description
The Mirus™ Circular Stapler are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location. Mirus™ Circular Stapler is preloaded with Staples.
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.
Mirus™ Hemorrhoids Circular Stapler is a set of instruments that places a circular row of titanium staples (double staggered) while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired. The Mirus™ Hemorrhoid circular stapler is preloaded with staples.
Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus™ Linear stapler are supplied separately
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K Number
K200166Device Name
Mirus Ligating Clip, Mirus Ligating Clip Applier
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2020-11-23
(306 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mirus™ Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.
Mirus™ Ligating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.
Device Description
Mirus™ Ligating clip are sterile, single use, implantable device made of implant grade titanium (ISO 5832-2 / ASTM F 67). The clips are available in various sizes with 6 clips packed in a single plastic cartridge.
Mirus™ Ligating clips are supplied with multiuse non sterile stainless steel Mirus™ Ligating Clip applier, allows the end user to ligate a wide range of vessels and tissue structures using the ligating clips
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K Number
K172146Device Name
MERISTEEL
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2018-02-01
(199 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
Device Description
MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands
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K Number
K172149Device Name
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2017-10-20
(95 days)
Product Code
GAP, GAR, GAT, GAW
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture. FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes. FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes. MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes. FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
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K Number
K172659Device Name
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2017-09-28
(23 days)
Product Code
GAM, NEW
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.
MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular or neurological tissues.
MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.
FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description
MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate.
MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate.
MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture.
FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone).
FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone).
All sutures are available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.
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K Number
K160623Device Name
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
Manufacturer
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
Date Cleared
2016-05-31
(88 days)
Product Code
GAP, GAR, GAT, GAW
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.
Device Description
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes.
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes.
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K Number
K150717Device Name
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2015-10-14
(209 days)
Product Code
GAM, NEW
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
M/s. Meril Endo Surgery Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.
MITSU suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FSTTM suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
FILAX YN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description
Not Found
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