HRQ · Hemostat
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | HRQ |
|---|---|
| Device Name | Hemostat |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920298 | DISPOSABLE HEMOSTATS | Falcon Instruments, Inc. | Aug 11, 1992 | SESE |
| K895683 | BERNARD VESSEL APPROXIMATOR | Applied Medical Technologies | Oct 24, 1989 | SESE |
| K890245 | SURGICAL HEMOSTATS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K884196 | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | Disposable Sterile Surgical Instruments, Inc. | Nov 8, 1988 | SESE |
| K881937 | SURGICAL INSTRUMENTS | Far East Intl. Trading Corp. | Jun 15, 1988 | SESE |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | Medcomp Technologies, Inc. | May 23, 1986 | SESE |
| K844152 | HEMSTATS | I M, Inc. | Nov 7, 1984 | SESE |
| K843593 | SURGIPRESS SURGICAL LOOP | Syntex Corp. | Oct 24, 1984 | SESE |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | Scanlan Intl., Inc. | Jun 5, 1984 | SESE |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K831797 | HEMOSTATS | I M, Inc. | Jul 19, 1983 | SESE |
| K823694 | VASCU-STATT APPROXIMATOR | Scanlan Intl., Inc. | Jan 7, 1983 | SESE |
| K822263 | VARIOUS TYPES OF TONSILS HEMOSTATS | Kelleher Corp. | Aug 16, 1982 | SESE |
| K821887 | SCANLAN SUTURE-STATT | Scanlan Intl., Inc. | Jul 28, 1982 | SESE |
| K821617 | DISPOSABLE HEMOSTATS | Medcare Products | Jun 21, 1982 | SESE |
Top Applicants
- Scanlan Intl., Inc. — 3 clearances
- I M, Inc. — 2 clearances
- Applied Medical Technologies — 1 clearance
- Disposable Sterile Surgical Instruments, Inc. — 1 clearance
- Falcon Instruments, Inc. — 1 clearance
