LIGA-LOOP SUTURE APPLICATOR
FDA 510(k) clearance K993695 · decided 2000-04-13
Clearance details
- K-number
- K993695
- Device name
- LIGA-LOOP SUTURE APPLICATOR
- Applicant
- Hysterx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-02
- Decision date
- 2000-04-13
- Days to decision
- 163 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
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| UNIPLAIN & UNICHROM (K042287) | United Medical Industries Co. , Ltd. | 2005-09-07 |
| AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (K042897) | Ethicon Endo-Surgery, Inc. | 2004-11-19 |
| 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 |
| PLAIN/CHROMIC CATGUT (K994002) | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
| AILEE SUTURES AND AILEE NEEDLES (K982646) | Myco Medical Supplies, Inc. | 1999-06-02 |
Recalls involving this device
No recalls on record reference this clearance.