510(k) K051281
- Device
- THE NEEDLE CATCHER
- Applicant
- E.D.MEDICAL LTD.
- 510(k) number
- K051281
- Product code
- HTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-08
- Date received
- 2005-05-17
- Regulation
- 878.4800
- Classification name
- Forceps
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN MCNICHOLL
- Address
- 32 Cranmore Ave. Lisburn Rd. Belfast GB BT96JH BT96JH
FDA Registration Numbers#
- 3017417635
- 1223656
- 3034688516
- 9710524
- 3009468807
- 3004122598
- 3006061749
- 1319639
- 8010769
- 3023155873
- 3012226300
- 2246990
- 3008812560
- 8040233
- 3004049923
- 8010591
- 8010422
- 1043534
- 9610809
- 3011248163
- 3010331645
- 3012241417
- 3016032497
- 1216677
- 3007518347
- 3002808270
- 3015156396
- 3027339877
- 3010726901
- 9613563
- 3008489813
- 8010250
- 3007773213
- 9680619
- 1058726
- 3005739886
- 3019269298
- 3012507533
- 3005987567
- 3010509633
- 1055890
- 3005587147
- 3004892425
- 3003244954
- 3005180920
- 3010221586
- 3010288346
- 8010935
- 8040373
- 3010829427
- 3016438694
- 8030607
- 3007699067
- 3010045785
- 8043752
- 3036795921
- 3045853999
- 9680515
- 3042940336
- 8010733
- 2529846
- 3015272949
- 3038187464
- 3032747418
- 1045379
- 1066741
- 3012777736
- 3003407244
- 3004519921
- 1923569
- 9680718
- 3012568936
- 1835998
- 8010665
- 8031020
- 2916714
- 1720747
- 1828288
- 3023657851
- 3025376090
Source Documents#
Other 510(k) Records For Product Code HTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974593 | SEMKIN INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K974594 | SEMKIN BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K974595 | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | Marlo Surgical Technology | 1991-10-23 |
| K911180 | CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS | Northgate Technologies, Inc. | 1991-03-29 |
| K895212 | TIK EXTRAKTOR | Instruments of Sweden, Inc. | 1989-09-27 |
| K890369 | GALL STONE FORCEPS | Kinetic Medical Products | 1989-02-03 |
| K890373 | HEMORRHOIDAL FORCEPS | Kinetic Medical Products | 1989-02-03 |
| K890213 | MICROSURGICAL FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890226 | SURGICAL FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890234 | SUTURE CLIP REMOVER | Kinetic Medical Products | 1989-01-27 |
| K890238 | CATHETER FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890244 | TUBING CLAMP FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890246 | ARTERY FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890257 | BONE CUTTING FORCEPS, DOUBLE-ACTION | Kinetic Medical Products | 1989-01-27 |
Legacy Summary#
summary
FDA Review#
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