FYF
32 FDA 510(k) clearances · Product code
32 daysmedian time to decision
120 days90th percentile
32clearances measured
FDA profile
- Official device name
- Cap, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SHOE COVER (K972227) | American Seal Co. | 1997-09-09 |
| NIOMED SURGICAL CAPS (K955833) | Amerasia Corp. | 1996-03-15 |
| SURGICAL CAP (K954556) | Thai Disposable Products Co., Ltd. | 1996-03-12 |
| NIOMED SURGICAL HOOD (K954454) | Amerasia Corp. | 1996-01-23 |
| NIOMED BOUFFANT CAPS (K954455) | Amerasia Corp. | 1996-01-23 |
| SURGEON'S CAP (K953879) | American Threshold Industries, Inc. | 1996-01-05 |
| BOUFFANT CAP (K953878) | American Threshold Industries, Inc. | 1996-01-05 |
| DISPOSABLE BOUFFANT CAP (K913700) | Gem Nonwovews, Inc. | 1991-10-04 |
| INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (K882346) | Nordbye, Milchman, Barlage | 1988-06-30 |
| SURGEONS CAP (K882284) | A Plus International, Inc. | 1988-06-23 |
| BOUFFANT CAP (K882283) | A Plus International, Inc. | 1988-06-23 |
| CARETEX SURGEON'S CAPS (K880481) | James River Corp. | 1988-02-24 |
| KIMBERLY-CLARK FULL COVERAGE HOOD (K875261) | Kimberly-Clark Corp. | 1988-01-22 |
| SURGICAL CAPS (K874066) | Interpro Intl., Inc. | 1987-11-04 |
| TECNOL SURGEON'S CAP (K873830) | Tecnol New Jersey Wound Care, Inc. | 1987-10-23 |
| VARIOUS TYES OF SURGICAL GARMENTS (K870617) | Greene International Corp. | 1987-03-09 |
| VARIOUS TYPES OF SURGICAL GARMENTS (K870618) | Kin Yuh Hung Co., Ltd. | 1987-03-09 |
| BOUFFANT-STYLE SURGICAL CAP (K863359) | Kimberly-Clark Corp. | 1986-09-29 |
| SURGICAL CAP CALOT (K851558) | Roseburg SA | 1985-04-30 |
| CAPS (O.R. NURSE, SURGICAL) (K844704) | Medicon, Inc. | 1985-01-10 |
| BOUNDARY HEADWEAR (K831357) | Procter & Gamble Mfg. Co. | 1983-06-02 |
| DISPOSABLE SURGERY CAPS & HOODS (K810199) | Anago, Inc. | 1981-02-13 |
| DISPOSABLE NURSES CAP (K802186) | Anago, Inc. | 1980-09-26 |
| FLARE DIS. NONWOVEN HEAD COVERS (K800810) | Flare Products, Inc. | 1980-05-20 |
| SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP (K800511) | American Convertors Div., American Pharmaseal | 1980-04-16 |
| CAP, CLARION NURSES OR (TECHNIC) (K770260) | Sherwood Medical Industries | 1977-03-07 |
| CAP, CLARION SURGEON'S (K770259) | Sherwood Medical Industries | 1977-03-07 |
| CAP, CLARION NURSES, STYLE BOUFFANT 21 (K770258) | Sherwood Medical Industries | 1977-03-07 |
| P.S.M. BOTIQUE CAP (K761069) | The Owenby Co. | 1976-12-30 |
| P.S.M. BOUFFANT CAP (K761068) | The Owenby Co. | 1976-12-30 |
| P.S.M. JUSTA KAP (K761071) | The Owenby Co. | 1976-12-30 |
| SURGICAL CORP. (K760861) | Surgikos, Inc. | 1976-11-03 |
Track FYF automatically
Every clearance here is in the API, with alerts when new ones post.