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#
- 9614069
- 2084346
- 3016050940
- 3004983210
- 9680718
- 3008386507
- 3015895045
- 9616250
- 9611102
- 3034669683
- 1836161
- 9611281
- 3007751820
- 3006061749
- 9611503
- 3004941127
- 3010509633
- 1221763
- 2936485
- 1423662
- 8041151
- 3010009693
- 9613350
- 3005973280
- 3013666218
- 3011625373
- 3016096142
- 3009465247
- 3008323540
- 3009106092
- 2132732
- 3003759558
- 1820334
- 3009381600
- 9611616
- 3000286616
- 3032747418
- 8043769
- 1223656
- 3013055499
- 8010944
- 3005067367
- 9613926
- 3013157831
- 2529846
- 3001297506
- 3023657851
- 3007187674
- 3014437893
- 3015877656
- 3004857344
- 1032347
- 3009718267
- 1054241
- 3042172872
- 3009703496
- 3006554912
- 3018097421
- 3005695838
- 3016825318
- 1018233
- 3011371465
- 3016851379
- 1644408
- 3005596514
- 3011987967
- 3003887292
- 3031240334
- 8043507
- 1220948
- 3006563559
- 3003882387
- 3031184338
- 3002090132
- 3010353847
- 3004049923
- 9611610
- 3026133770
- 3010041511
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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