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Found 13 results
510(k) Data Aggregation
K Number
K051487Device Name
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2005-12-22
(199 days)
Product Code
KHJ
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.
Device Description
Laryngeal Augmentation Implant
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K Number
K041018Device Name
DRG SOFTRELEASE
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2004-10-18
(181 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). DRG SoftRelease is not intended for use in pregnant women.
Device Description
The DRG SoftRelease is a single use, disposable, manual gynecological device intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). The device consists of a handle with a release mechanism, a spatula disc, and a brush. The common handle / release combination allows the attachment of a brush attachment for use in cervical or vaginal wall cell collection. The attachment of either the spatula or the brush allows for the release of the cell collector attachments from the device handle.
The brush is composed of bristles joined to a wire shaft. For collecting cervical cells, the brush is inserted into the cervix until only the last row of bristles are visible, rotated once via the handle, and removed from the site for transfer of the cytological material.
The spatula is made of plastic and is curve-shaped, similar to the widely used Ayre spatula. For collecting cervical cells, the spatula's blunt edge is placed against the cervix, rotated with gentle pressure on the handle, and removed from the site for transfer of the cytological material.
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K Number
K012535Device Name
DRG DISPOSABLE VAGINAL SPECULUM
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2002-03-01
(206 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG Disposable Vaginal Speculum is indicated for use to expose the interior of the vagina.
The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.
Device Description
The DRG Disposable Vaginal Speculum consists of a plastic inflatable bladder The DNO Disposable Vaginal of to uniformly press the vaginal walls open.
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K Number
K012003Device Name
DRG REACTION CHAMBER/SAFETY TIP
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2002-02-12
(230 days)
Product Code
HEI, GEI
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.
Device Description
The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.
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K Number
K011736Device Name
DRG QUICKMIX
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2002-01-30
(239 days)
Product Code
GXP, FWP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
Device Description
The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it. The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.
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K Number
K013786Device Name
DRG ORTHOHEX SS BONE SCREW
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2001-12-17
(33 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG OrthoHex SS bone screws are intended for orthopedic trauma and reconstruction.
Device Description
DRG OrthoHex SS Bone Screw
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K Number
K002047Device Name
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
2000-11-22
(139 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991714Device Name
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
1999-12-10
(204 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.
Device Description
Conventional Electronic Digital Stethoscope
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K Number
K990212Device Name
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
1999-09-14
(235 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.
Device Description
DRG LockJaw™ 15 Minute Intermaxillary Fixation System
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K Number
K990920Device Name
DRG TITANIUM BONE PLATE
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
1999-06-10
(84 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
DOCTOR'S RESEARCH GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.
Device Description
DRG Titanium Bone Plate
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