AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
FDA 510(k) clearance K904588 · decided 1990-12-24
Clearance details
- K-number
- K904588
- Device name
- AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1990-09-26
- Decision date
- 1990-12-24
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GAL
- Device class
- 2
- Regulation number
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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| SUTURTEK FASTCLOSE SUTURING DEVICE (K030227) | Suturtek Incorporated | 2003-03-17 |
| SERRALGUT (K020597) | Serral, S.A. DE C.V. | 2002-08-14 |
| GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043) | Gramsmed, LLC | 2002-06-21 |
| SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105) | Qrc Consulting | 2001-05-30 |
| PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (K001299) | Cp Medical | 2000-06-23 |
| PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (K000542) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| LIGA-LOOP SUTURE APPLICATOR (K993695) | Hysterx, Inc. | 2000-04-13 |
| PLAIN/CHROMIC CATGUT (K994002) | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
Recalls involving this device
No recalls on record reference this clearance.