MDM · Instrument, Manual, Surgical, General Use
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | MDM |
|---|---|
| Device Name | Instrument, Manual, Surgical, General Use |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 44)
Showing 20 most recent of 44 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | Aug 8, 2008 | SESE |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | Aug 15, 2005 | SESE |
| K050957 | EUTROCHAR | Special Devices, Inc. | May 18, 2005 | SESE |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | Dec 18, 2002 | SESE |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | Nov 13, 2002 | SESE |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | Dec 7, 2001 | SESE |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | Jun 22, 2001 | SESE |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | Mar 30, 1999 | SESE |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | Jul 9, 1998 | SESE |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | Mar 1, 1995 | SESE |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | Nov 28, 1994 | SESE |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | Nov 9, 1994 | SESE |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | Aug 26, 1994 | SESE |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | Aug 25, 1994 | SESE |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | Jul 19, 1994 | SESE |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | Mar 14, 1994 | SESE |
| K933265 | ACU-DISPO-CE(TM) | Acuderm, Inc. | Mar 7, 1994 | SESE |
| K933866 | ACU-HEMOSTATIC RING | Acuderm, Inc. | Dec 1, 1993 | SESE |
| K925653 | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH | Dermatopathology Laboratory | Nov 8, 1993 | SESE |
| K922130 | HOSPITAL KIT DK 117 | Savoy Medical Supply Co., Inc. | May 24, 1993 | SEKD |
Top Applicants
- Savoy Medical Supply Co., Inc. — 4 clearances
- Falcon Instruments, Inc. — 3 clearances
- Acuderm, Inc. — 2 clearances
- Deroyal Industries, Inc. — 2 clearances
- American Biomaterials Corp. — 1 clearance
