SURGICAL INSTRUMENTS
FDA 510(k) clearance K881937 · decided 1988-06-15
Clearance details
- K-number
- K881937
- Device name
- SURGICAL INSTRUMENTS
- Applicant
- Far East Intl. Trading Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-09
- Decision date
- 1988-06-15
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- HRQ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE HEMOSTATS (K920298) | Falcon Instruments, Inc. | 1992-08-11 |
| BERNARD VESSEL APPROXIMATOR (K895683) | Applied Medical Technologies | 1989-10-24 |
| SURGICAL HEMOSTATS (K890245) | Kinetic Medical Products | 1989-01-27 |
| SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) (K884196) | Disposable Sterile Surgical Instruments, Inc. | 1988-11-08 |
| MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) (K861807) | Medcomp Technologies, Inc. | 1986-05-23 |
| HEMSTATS (K844152) | I M, Inc. | 1984-11-07 |
| SURGIPRESS SURGICAL LOOP (K843593) | Syntex Corp. | 1984-10-24 |
| SCANLAN VASCU-STATT II APPROXIMATOR (K841514) | Scanlan Intl., Inc. | 1984-06-05 |
| OP-CON SURG. INSTRUMENTS #11 (K834175) | Imm Enterprises , Ltd. | 1984-01-27 |
| HEMOSTATS (K831797) | I M, Inc. | 1983-07-19 |
| VASCU-STATT APPROXIMATOR (K823694) | Scanlan Intl., Inc. | 1983-01-07 |
| VARIOUS TYPES OF TONSILS HEMOSTATS (K822263) | Kelleher Corp. | 1982-08-16 |
Recalls involving this device
No recalls on record reference this clearance.