MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
FDA 510(k) clearance K920706 · decided 1993-05-26
Clearance details
- K-number
- K920706
- Device name
- MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
- Applicant
- Retrax
- Decision
- Substantially Equivalent
- Date received
- 1992-02-18
- Decision date
- 1993-05-26
- Days to decision
- 463 days
- Clearance type
- Traditional
- Product code
- FHQ
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wausau, WI, 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 |
|---|---|---|
| WINGED NEEDLE HOLDER (K974327) | Phx Technologies Corp. | 1998-01-09 |
| LAPAROSCOPIC NEEDLE HOLDER (K924196) | Nusurg, Inc. | 1993-06-25 |
| ENDOSCOPIC NEEDLEHOLDER, MODIFICATION (K930330) | Holmed Corp. | 1993-06-08 |
| 25-100,25-220 VARIOUS NEEDLE HOLDERS (K851779) | Artiberia | 1985-06-20 |
| 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS (K851780) | Artiberia | 1985-06-20 |
| NEEDLE HOLDER, MICROVASCULAR (K771859) | Edward Weck, Inc. | 1977-10-04 |
Recalls involving this device
No recalls on record reference this clearance.