GAD · Retractor
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GAD |
|---|---|
| Device Name | Retractor |
| 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 100)
Showing 20 most recent of 100 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | Apr 13, 2016 | SESE |
| K151104 | OTELO LL | Spineart | Jan 6, 2016 | SESE |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | Oct 4, 2013 | SESE |
| K071775 | DASH | Ezsurgical | Aug 7, 2007 | SESE |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | Apr 26, 2005 | SESE |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | Feb 23, 2005 | SESE |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | May 17, 2000 | SESE |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | Aug 18, 1998 | SESE |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | Sep 20, 1996 | SESE |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | Nov 9, 1994 | SESE |
| K942002 | RETRACTOR | Automated Medical Products Corp. | May 17, 1994 | SESE |
| K941448 | RETRACTOR | Technovations | Apr 15, 1994 | SESE |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | Feb 10, 1994 | SESE |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | Aug 6, 1993 | SESE |
| K921020 | HARGIS SELF RETRACTION SYSTEM | Medin Corp. | Jul 2, 1993 | SESE |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Medin Corp. | Jul 2, 1993 | SESE |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | Jul 2, 1993 | SESE |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Andronic Devices, Ltd. | Oct 19, 1992 | SESE |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Andronic Devices, Ltd. | Oct 19, 1992 | SESE |
| K920471 | LEVY ARTICULATING RETRACTOR | Lifeguard Medical Products, Inc. | Jun 23, 1992 | SESE |
Top Applicants
- T. Korossurgical Instruments Corp. — 8 clearances
- Edward Weck, Inc. — 4 clearances
- Karlin Technology, Inc. — 3 clearances
- Kinetic Medical Products — 3 clearances
- Medin Corp. — 3 clearances
