DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
FDA 510(k) clearance K092827 · decided 2010-01-08
Clearance details
- K-number
- K092827
- Device name
- DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
- Applicant
- Dimeda Instrumente GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-09-14
- Decision date
- 2010-01-08
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- HDA
- Device class
- 2
- Regulation number
- 884.4400
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (K100517) | Instrumed International, Inc. | 2010-04-29 |
| TEKNO-MEDICAL OBSTETRICAL FORCEPS (K013747) | Tekno Medical Optik-Chirurgie GmbH & Co. | 2002-02-11 |
| V. MUELLER OBSTETRICAL (OB) FORCEPS (K951529) | Baxter Healthcare Corp | 1995-08-04 |
| CMI VACUUM PUMP (K914552) | Columbia Medical & Surgical, Inc. | 1993-09-07 |
| ILC FORCEPS PADS (K905583) | Inman Liebelt Corp. | 1991-04-12 |
| AUTO SUTURE(R) ENDOSCOPIC CLAMP (K903205) | United States Surgical, A Division of Tyco Healthc | 1990-10-11 |
| MIDWIFERY/OBSTETRICAL FORCEPS (K890385) | Kinetic Medical Products | 1989-03-01 |
| SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 (K851883) | The Huxley Instrument Corp. | 1985-05-09 |
| FORCEPS, OB, NON-COMPRESSIVE (K771106) | Zeppelin Medizinlechnik GmbH | 1977-07-01 |
Recalls involving this device
No recalls on record reference this clearance.