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#
- 3003882387
- 3003694247
- 3009865268
- 3005809810
- 3005641619
- 2183449
- 3015451162
- 9613079
- 9611390
- 3002719998
- 3009703496
- 9611112
- 3002808270
- 3001620590
- 8010935
- 3016851379
- 1055890
- 3003675041
- 3009513193
- 8010732
- 3035678069
- 3021010222
- 8010890
- 9680519
- 3038503932
- 9613369
- 3010303097
- 9613350
- 3014207283
- 3010123206
- 8041151
- 3007366790
- 9615005
- 3014662844
- 8031020
- 1030489
- 3009971621
- 3017565094
- 3002579136
- 9615765
- 3009887475
- 3006563559
- 3004992978
- 3005813597
- 9681161
- 1834331
- 3036756245
- 3004608878
- 3010065126
- 3010057495
- 1531174
- 3008110533
- 3013784566
- 3005012805
- 1423537
- 2133928
- 3008489813
- 3013660200
- 3004598675
- 3014840003
- 1526439
- 3007675948
- 3004911384
- 3003407244
- 3033858895
- 3005595283
- 2518902
- 8040233
- 3010220595
- 3014334038
- 3008770252
- 3009158523
- 1061124
- 3014268446
- 3010155661
- 9616250
- 1828464
- 3004083789
- 1818910
- 8010370
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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