510(k) K853538
- Device
- CANNULA CLAMP
- Applicant
- CP MEDICAL
- 510(k) number
- K853538
- Product code
- HXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-12
- Date received
- 1985-08-23
- Regulation
- 878.4800
- Classification name
- Clamp
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL GRODACH
- Address
- 1775 Whittier Ave. Costa Mesa CA US 92627 92627
FDA Registration Numbers#
- 1720747
- 3004450489
- 8043496
- 3024988980
- 3031231776
- 3004111573
- 3010455030
- 3011529314
- 3009703496
- 3006563559
- 9611503
- 8010303
- 2424531
- 3004187715
- 3008936260
- 3015512299
- 2434839
- 3011230048
- 3036756245
- 3034676720
- 8040233
- 3003882387
- 8010422
- 8040373
- 3009968482
- 1219655
- 9614075
- 3027242374
- 3033536312
- 3004083789
- 9681161
- 3002808270
- 3006061749
- 1421101
- 3005595283
- 3007913880
- 3003687489
- 3004193466
- 3005809810
- 1824619
- 1648571
- 1043214
- 3008110533
- 3004598675
- 3017565094
- 3013156185
- 1833053
- 3027556548
- 1644312
- 3010331645
- 1646747
- 1423537
- 1526439
- 2031963
- 3005528784
- 3010220595
- 3001408183
- 9680518
- 3001297506
- 3010687973
- 3014314623
- 3007675948
- 3006554912
- 1056350
- 3008489813
- 1054241
- 1421879
- 3025376090
- 9616671
- 9680515
- 3003694247
- 3006487092
- 9680519
- 1043534
- 8010704
- 3015516266
- 8010177
- 8010168
- 3003807268
- 3011524630
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HXD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890368 | KIDNEY CLAMP | Kinetic Medical Products | 1989-02-03 |
| K890371 | INTESTINAL CRUSHING CLAMP | Kinetic Medical Products | 1989-02-03 |
| K890372 | INTESTINAL CLAMP | Kinetic Medical Products | 1989-02-03 |
| K890381 | PARAMETRIUM CLAMP | Kinetic Medical Products | 1989-02-03 |
| K874959 | VASCULAR CLAMP | Solway, Inc. | 1987-12-30 |
| K872386 | C CLAMP | Med-Tool, Inc. | 1987-07-02 |
| K863653 | SUCTION-OFF | B&B Medical Technologies, Inc. | 1986-10-07 |
| K851654 | OMNIMED CLAMP | Omni Intl., Inc. | 1985-05-31 |
| K801819 | SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | 1980-08-20 |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | 1980-05-20 |
| K791289 | GIZMO TOWEL CLAMP | Hemoy, Inc. | 1979-07-24 |
| K782090 | CLAMP, DISPOSABLE | Concord Laboratories, Inc. | 1978-12-20 |
| K770118 | CARPENTER BONE CLAMP | Stryker Corp. | 1977-01-26 |
Legacy Summary#
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FDA Review#
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