510(k) K930330
- Device
- ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
- Applicant
- Holmed Corp.
- 510(k) number
- K930330
- Product code
- FHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-08
- Date received
- 1993-01-22
- Regulation
- 876.4730
- Classification name
- Holder, Needle, Gastroenterologic
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL P HOLMES
- Address
- 40 Norfolk Ave. South Easton MA US 02375 02375
FDA Registration Numbers#
- 1000175697
- 1526534
- 3003882387
- 8043404
- 3043355002
- 3005809810
- 3015451162
- 9613079
- 9611390
- 8043769
- 3010202439
- 8010269
- 3015393204
- 9611112
- 3014579161
- 9610617
- 3001620590
- 3003700106
- 3007518347
- 3001644167
- 1055890
- 3003675041
- 3009513193
- 3035678069
- 3011585752
- 3009468807
- 3043226252
- 9680519
- 3002090132
- 3013011598
- 9681129
- 3029082594
- 2124215
- 1055236
- 9611367
- 8040172
- 1216677
- 3012494290
- 2031962
- 1450019
- 3003877407
- 3022747125
- 8040381
- 3015177648
- 3003322138
- 3005177644
- 2521877
- 3002769835
- 9681161
- 3004001706
- 1935627
- 3005418651
- 8010099
- 3004608878
- 9611502
- 3013784566
- 3002862271
- 3005012805
- 3006846581
- 1423537
- 3003032798
- 5906
- 3004598675
- 3005225959
- 2183570
- 1063382
- 3035708926
- 3002294946
- 1000443955
- 3032109
- 1921846
- 3007407626
- 3009561692
- 3003407244
- 3008828237
- 8022787
- 8040233
- 3014334038
- 3008770252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974327 | WINGED NEEDLE HOLDER | Phx Technologies Corp. | 1998-01-09 |
| K924196 | LAPAROSCOPIC NEEDLE HOLDER | Nusurg, Inc. | 1993-06-25 |
| K920706 | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | Retrax | 1993-05-26 |
| K851779 | 25-100,25-220 VARIOUS NEEDLE HOLDERS | Artiberia | 1985-06-20 |
| K851780 | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | Artiberia | 1985-06-20 |
| K771859 | NEEDLE HOLDER, MICROVASCULAR | Edward Weck, Inc. | 1977-10-04 |