FDA Product Code
FDA Product Code KDC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K943229 | DISPOSABLE SURGICAL SCISSORS AND FORCEPS | Y.M.K. International Co., Ltd. | 1994-08-19 | Traditional | PDF ↗ |
| K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | Meadox Medicals, Div. Boston Scientific Corp. | 1994-03-07 | Traditional | PDF ↗ |
| K920153 | THERMUFF BAG | Techstyles | 1992-07-01 | Traditional | PDF ↗ |
| K920263 | MANUAL SURGICAL INSTRUMENTS | Phoenix Instruments Div. | 1992-05-06 | Traditional | PDF ↗ |
| K915064 | DISPOSABLE CAUTERY ABRASIVE PAD | American Medical Mfg., Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K914960 | INSTRUMENT ORGANIZER | O.R. Concepts, Inc. | 1992-02-28 | Traditional | PDF ↗ |
| K912834 | SHUR-GRIP | Inman Medical Corp. | 1991-07-26 | Traditional | PDF ↗ |
| K910079 | DISPOSABLE INTRODUCER SHEATH | Applied Vascular Devices, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K905240 | VESSELOOPS | Sparta Surgical Corp. | 1991-02-06 | Traditional | PDF ↗ |
| K903649 | BRADLEY TENACULUM HOLDER | Marlo Surgical Technology | 1990-11-02 | Traditional | PDF ↗ |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | Richard-Allan Medical Ind., Inc. | 1990-05-03 | Traditional | PDF ↗ |
| K896676 | KEY VASCULAR LOOPS | Key Surgical, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K854898 | ATLANTIC GRASPER | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854901 | PACIFIC GRASPER | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854895 | BASKET FORCEP | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854894 | SPOON | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854897 | MAX-I-GRASP | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854896 | HOOK SCISSOR | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K854890 | HOOK PROBE | Euro-Med Intl. | 1986-05-02 | Traditional | PDF ↗ |
| K853597 | INSTRUMENT MAKAR DISPOSALBE LOOP | Instrument Makar, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K832441 | SUTURE-AID BOOTIES | Omega-Med Intl., Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K833355 | SDC VASCULAR TIES | Science Development Corp. | 1984-01-27 | Traditional | PDF ↗ |
| K831118 | PMT-OPTICA LINE | Pmt, Inc. | 1984-01-25 | Traditional | PDF ↗ |
| K832680 | MICRO-EDGE DISPOSABLE BLADES | Micromedics, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K830800 | C-LOOPS | Concept, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K831842 | DRAVON T CLAMP | Dravon Medical, Inc. | 1983-09-26 | Traditional | PDF ↗ |
| K831665 | DISPOSABLE NEEDLE HOLDER | Medcare Products | 1983-09-12 | Traditional | PDF ↗ |
| K831664 | PLASTIC THUMB FORCEPS | Medcare Products | 1983-09-12 | Traditional | PDF ↗ |
| K831911 | DISPOSABLE FLOOR INSTRUMENTS | Ormed Mfg., Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831915 | SAFETY PINS & RUBBER BANDS | Ormed Mfg., Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831661 | DISPOSABLE SCISSORS | Medcare Products | 1983-08-25 | Traditional | PDF ↗ |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Medcare Products | 1983-07-19 | Traditional | PDF ↗ |
| K831798 | DISPOSABLE SCALPELS | I M, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K830248 | DEVO'N LOOPS | Devon Industries, Inc. | 1983-03-08 | Traditional | PDF ↗ |
| K830326 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE | Erika, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K822065 | KAM SUCKER | The Anspach Effort, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K821166 | KOLOR KODE TM | Devon Industries, Inc. | 1982-05-13 | Traditional | PDF ↗ |
| K820638 | PEDIATRIC SUCKER | 3M Health Care, Sarns | 1982-04-09 | Traditional | PDF ↗ |
| K820161 | AXIOM LIG-A-BOOTS | Axiom Medical, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K820158 | OLSEN #770 DISPOSABLE HOLSTER | Olsen Electro-Surgical Instruments, Inc. | 1982-02-05 | Traditional | PDF ↗ |
| K811823 | SHARPS CADDY FB | Instranetics, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811822 | TIP-VU | Instranetics, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811824 | CAUTERY CADDY PAD | Instranetics, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811712 | TIP WIPE | Devon Industries, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811303 | ALTRACLUDE | R&H Medical, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811280 | FLEX-TEMPLATE | Mick Radio-Nuclear Instruments, Inc. | 1981-06-02 | Traditional | PDF ↗ |
| K811191 | DAVIS & GECK NEEDLE/SHARPS COUNTER | Davis & Geck, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K811120 | SURGICAL STAPLE REMOVER | Acme United Corp. | 1981-05-05 | Traditional | PDF ↗ |
| K810883 | OMED SILICONE INSTRUMENT COVERS | Omega-Med Intl., Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810785 | SKIN STAPLE REMOVER | Rowley Mfg. Co. | 1981-04-10 | Traditional | PDF ↗ |
| K810080 | VASCULAR TIE (VAS-TIE) | Sil-Med Corp. | 1981-04-02 | Traditional | PDF ↗ |
| K810269 | OMED FABRIC INSTRUMENT COVERS | Omega-Med Intl., Inc. | 1981-02-26 | Traditional | PDF ↗ |
| K810260 | OMED SILICONE LOOPS | Omega-Med Intl., Inc. | 1981-02-26 | Traditional | PDF ↗ |
| K802485 | SEARLE VASCULAR LOOPS | G.D. Searle and Co. | 1981-02-12 | Traditional | PDF ↗ |
| K810112 | SWR DISPOSABLE PREP RAZOR | G.D. Searle and Co. | 1981-02-04 | Traditional | PDF ↗ |
| K803156 | SURGITEK MEDI-LOOPS | Medical Engineering Corp. | 1981-01-15 | Traditional | PDF ↗ |
| K802895 | COBE CENTRY 2 VARIABLE CONCENTRATE-18- | Cobe Laboratories, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802865 | SAFE T COUNT | Instranetics, Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K802866 | SHARPS CADDY MAGNETIC & SHARPS CADDY FOA | Instranetics, Inc. | 1980-11-17 | Traditional | PDF ↗ |
| K801908 | SI-14 | Kmi Medical, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800015 | AXIOM VESSEL LOOPS | Axiom Medical, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K791434 | SPONGE COUNTER BAGS | Medicare Industries, Inc. | 1979-10-09 | Traditional | PDF ↗ |
| K780880 | Y-TYPE BLOOD SET | Abbott Laboratories | 1978-06-30 | Traditional | PDF ↗ |
| K780399 | INSTRUMENT CLEANING BRUSH | Ransom and Randolph | 1978-03-17 | Traditional | PDF ↗ |
| K771702 | VESSEL-STABILIZER | Med General | 1977-12-13 | Traditional | PDF ↗ |
| K770794 | SUTURE REMOVAL SET, STERILE | Lukens Corp. | 1977-05-06 | Traditional | PDF ↗ |
| K760362 | LANCET, BLOOD, STERILE STAINLESS STEEL | Aeroceuticals | 1976-09-13 | Traditional | PDF ↗ |
Product code KDC · Class I · General, Plastic Surgery. Data: openFDA.