510(k) K792378
- Device
- HEMOSPENSER CARTRIDGE CAT. NO. 523500-
- Applicant
- EDWARD WECK, INC.
- 510(k) number
- K792378
- Product code
- GDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-06
- Date received
- 1979-11-26
- Regulation
- 878.4800
- Classification name
- Applier, Surgical, Clip
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011052945
- 3023657851
- 9611112
- 3005440795
- 8010591
- 3004215117
- 2249529
- 2431166
- 2647580
- 3007361214
- 1421879
- 1056350
- 1061124
- 3020965506
- 3004892425
- 8040278
- 8010099
- 3010041511
- 3035678069
- 3010687973
- 3014615697
- 1066959
- 3004944585
- 2027170
- 9611283
- 9612501
- 3004111573
- 3007597038
- 3005075853
- 3014257776
- 3010399422
- 3010055973
- 3003759558
- 2320762
- 3003244954
- 1054241
- 3015895045
- 8040179
- 3008808049
- 8010518
- 3008285983
- 9610557
- 3004001706
- 3010667733
- 1836161
- 3025376090
- 1062741
- 3029082594
- 3002807090
- 3035708926
- 3031231776
- 2436906
- 1220724
- 1648701
- 3016678045
- 1043214
- 3014268446
- 1219930
- 3010605922
- 3042172872
- 8040884
- 2424366
- 9710649
- 9611503
- 3003418325
- 3031564283
- 3031261833
- 1226015
- 2085947
- 3009498536
- 3033536312
- 1222274
- 3013557562
- 9616250
- 1055236
- 1416980
- 8010890
- 3007675948
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Unisurge, Inc. | 1993-04-20 |
| K890941 | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP | United States Surgical, A Division of Tyco Healthc | 1989-04-07 |
| K890159 | TOWEL CLIPS | Dhason Brothers, Inc. | 1989-02-03 |
| K890233 | SUTURE CLIP APPLIER/REMOVER | Kinetic Medical Products | 1989-01-27 |
| K820837 | DISPOSABLE MULTIPLE LIGATING CLIP | ETHICON, Inc. | 1982-05-28 |
| K812291 | ETHICON MULTIPLE LIGATING CLIP APPLIER | ETHICON, Inc. | 1981-09-11 |
| K791845 | BAYONET HEIFETZ CLIP APPLIERS | Edward Weck, Inc. | 1979-10-17 |
| K790855 | SURGICAL DRAPE CLIP #201 | C. Intl. | 1979-08-03 |
| K791157 | 360 HEMOCLIP APPLIERS | Edward Weck, Inc. | 1979-06-27 |
| K790990 | REYNOLDS DOUBLE HEMOCLIP APPLIERS | Edward Weck, Inc. | 1979-06-05 |
| K772286 | FORCEPS, SUTURE, AUTO | Hartmann Group, Inc. | 1977-12-20 |
| K771412 | LIGACLIP MULTIPLE CLIP APPLIER | ETHICON, Inc. | 1977-11-28 |
| K771640 | SUTURE CLIP REMOVER | United States Surgical, A Division of Tyco Healthc | 1977-09-30 |
Legacy Summary#
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FDA Review#
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