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#
- 3010687973
- 3011260488
- 3013046958
- 1722511
- 3009882675
- 1835572
- 3015451162
- 3036795921
- 1043534
- 3014004349
- 1931563
- 1421879
- 3010455030
- 1423537
- 9613418
- 1648571
- 3022748632
- 3003597504
- 9680794
- 3003418325
- 2084346
- 3003431869
- 8030607
- 3003334541
- 3011600579
- 3003687489
- 9680002
- 3007539489
- 3005596514
- 1061124
- 3010123206
- 3010370500
- 3008902714
- 8010298
- 3006210673
- 3014840003
- 9616088
- 3006460162
- 3004111573
- 2183449
- 3002808270
- 9613350
- 3014268446
- 9615765
- 3006395932
- 3008489813
- 3006563559
- 9680519
- 3002976036
- 8043441
- 1220246
- 3007597038
- 3001620590
- 3016069968
- 3004641308
- 2080222
- 1834331
- 8010422
- 3004608878
- 3009888740
- 3015173212
- 3011524630
- 1058726
- 3008110533
- 3007675948
- 3010536692
- 2320762
- 3007420745
- 3008252904
- 3004638532
- 3016965929
- 3008812560
- 3008850074
- 3035678069
- 9612086
- 8010252
- 2031963
- 2424366
- 3033509898
- 8040373
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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