FTY · Tape, Measuring, Rulers And Calipers
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FTY |
|---|---|
| Device Name | Tape, Measuring, Rulers And Calipers |
| 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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160501 | Noxilizer Surgical Ruler | Noxilizer, Inc. | May 26, 2016 | SESE |
| K951064 | DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC | S-E Sales & Distribution, Inc. | May 19, 1995 | SESE |
| K934930 | OLYMPIC AUTO-LENGTH | Olympic Medical Corp. | Dec 29, 1993 | SESE |
| K932112 | OLYMPIC INFA-LENGTH | Olympic Medical Corp. | Jul 22, 1993 | SESE |
| K883485 | STRYKER PRESSURE MONITOR SYSTEM | Stryker Corp. | Sep 13, 1988 | SESE |
| K880441 | PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. | Plane Iii, Inc. | Feb 18, 1988 | SESE |
| K874352 | TUMORIMETER | Cancer Technologies, Inc. | Nov 23, 1987 | SESE |
| K873470 | TEMPLATE | Cox-Uphuff Intl. | Sep 8, 1987 | SESE |
| K872319 | LN 100 BREAST MARKER | Instrumentation Industries, Inc. | Aug 11, 1987 | SESE |
| K863409 | KUNDIN WOUND GAUGE | Jane I. Kundin | Sep 29, 1986 | SESE |
| K862576 | PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) | Professional Services For Surgeons, Ltd. | Jul 15, 1986 | SESE |
| K860912 | PS2 BRAND MAMMAPLASTY | Professional Services For Surgeons, Ltd. | Mar 24, 1986 | SESE |
| K854892 | RULER | Euro-Med Intl. | Dec 24, 1985 | SESE |
| K840651 | MOLE-MARKER | Notation Systems, Inc. | Mar 12, 1984 | SESE |
| K832899 | ZIMMER OSSIMETER | Zimmer, Inc. | Oct 14, 1983 | SESE |
| K831041 | SAGITTAL KNEE TESTER | Orthopedic Systems, Inc. | Jun 24, 1983 | SESE |
| K812713 | DRAWER TEST | Medmetric Corp. | Nov 5, 1981 | SESE |
| K812069 | BORES* DEPTH GAUGE | Santa Barbara Medco, Inc. | Aug 31, 1981 | SESE |
| K811278 | EXTENDED TUMOR CALIPER | Mick Radio-Nuclear Instruments, Inc. | Jun 2, 1981 | SESE |
| K801939 | RHYTIDOMETER | Aztec Medical Products, Inc. | Sep 26, 1980 | SESE |
Top Applicants
- Olympic Medical Corp. — 2 clearances
- Professional Services For Surgeons, Ltd. — 2 clearances
- Aztec Medical Products, Inc. — 1 clearance
- Cancer Technologies, Inc. — 1 clearance
- Cox-Uphuff Intl. — 1 clearance
