GABBAY-FRATER SUTURE GUIDE
FDA 510(k) clearance K802093 · decided 1980-09-26
Clearance details
- K-number
- K802093
- Device name
- GABBAY-FRATER SUTURE GUIDE
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-02
- Decision date
- 1980-09-26
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FZX
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PARALLELING GUIDES (K914715) | Implant Corp. of America | 1994-02-16 |
| CIVCO STEPPER (K871413) | CIVCO Medical Instruments Co., Inc. | 1987-07-14 |
| BIOPSY NEEDLE GUIDE KIT, STERILE (K871503) | Amedic USA | 1987-07-10 |
| A.C.L. GUIDE KIT (K862564) | Aspen Laboratories, Inc. | 1986-08-18 |
| MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (K854262) | Meadox Surgimed, Inc. | 1985-12-24 |
| NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (K852402) | North American Instrument Corp. | 1985-07-11 |
| BRITISH SPINAL FUSION SET (K842698) | Downs Surgical , Ltd. | 1984-09-12 |
| THREADING TUBE (K841618) | Plastafil, Inc. | 1984-08-27 |
| DRILL GUIDE (K841619) | Plastafil, Inc. | 1984-07-11 |
| TECHMEDICA DRILL GUIDE (K841297) | Techmedica, Inc. | 1984-04-25 |
| STRAITH DRAIN INSERTER (K840835) | Surgical Technology Laboratories, Inc. | 1984-04-23 |
| ACUFEX DREZ COMMUNICATING DRILL GUIDE (K834350) | Acufex Microsurgical, Inc. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |