FLEXIBLE GRASPING FORCEPS
FDA 510(k) clearance K854112 · decided 1986-03-12
Clearance details
- K-number
- K854112
- Device name
- FLEXIBLE GRASPING FORCEPS
- Applicant
- Hood Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-10-08
- Decision date
- 1986-03-12
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- EWL
- Device class
- 2
- Regulation number
- 874.3730
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Pembroke, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hood Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FirstFit Surgical Kit (K240763) | Freudenberg Medical, LLC | 2024-12-18 |
| PROVOX FREEHANDS FLEXIVOICE (K141380) | Atos Medical AB | 2014-09-26 |
| PROVOX VEGA PUNCTURE SET (K131947) | Atos Medical AB | 2013-10-18 |
| PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (K092593) | Atos Medical AB | 2010-10-14 |
| BLOM-SINGER INDWELLING TEP OCCLUDER (K093258) | Helix Medical, LLC | 2010-03-03 |
| PROVOX VEGA, MODEL 8130-8135 (K090455) | Atos Medical AB | 2009-06-05 |
| BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES (K082206) | Helix Medical, LLC | 2008-09-04 |
| PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (K043138) | Atos Medical AB | 2004-11-22 |
| PROVOX FREEHANDS HME, MODEL 7710 (K022125) | Atos Medical AB | 2002-07-30 |
| BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (K991587) | Helix Medical, Inc. | 1999-06-25 |
| VOICE MASTER PROSTHESIS (K974132) | E. Benson Hood Lab, Inc. | 1998-02-25 |
| PROVOX 2 VOICE PROSTHESIS SYSTEM (K971244) | Atos Medical AB | 1997-06-06 |
Recalls involving this device
No recalls on record reference this clearance.