CARPENTER BONE CLAMP
FDA 510(k) clearance K770118 · decided 1977-01-26
Clearance details
- K-number
- K770118
- Device name
- CARPENTER BONE CLAMP
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-21
- Decision date
- 1977-01-26
- Days to decision
- 5 days
- Clearance type
- Traditional
- Product code
- HXD
- 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 |
|---|---|---|
| KIDNEY CLAMP (K890368) | Kinetic Medical Products | 1989-02-03 |
| INTESTINAL CRUSHING CLAMP (K890371) | Kinetic Medical Products | 1989-02-03 |
| INTESTINAL CLAMP (K890372) | Kinetic Medical Products | 1989-02-03 |
| PARAMETRIUM CLAMP (K890381) | Kinetic Medical Products | 1989-02-03 |
| VASCULAR CLAMP (K874959) | Solway, Inc. | 1987-12-30 |
| C CLAMP (K872386) | Med-Tool, Inc. | 1987-07-02 |
| SUCTION-OFF (K863653) | B&B Medical Technologies, Inc. | 1986-10-07 |
| CANNULA CLAMP (K853538) | Cp Medical | 1985-09-12 |
| OMNIMED CLAMP (K851654) | Omni Intl., Inc. | 1985-05-31 |
| SURGICAL INSTRUMENTS (K801819) | Robert I. Chien & Assoc., Inc. | 1980-08-20 |
| RICA OR SMIC SURGICAL INSTRUMENTS (K801028) | Robert I. Chien & Assoc., Inc. | 1980-05-20 |
| GIZMO TOWEL CLAMP (K791289) | Hemoy, Inc. | 1979-07-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |