PEDI VAGINAL ASPIRATOR
FDA 510(k) clearance K954903 · decided 1996-04-29
Clearance details
- K-number
- K954903
- Device name
- PEDI VAGINAL ASPIRATOR
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-25
- Decision date
- 1996-04-29
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- HFC
- Device class
- 2
- Regulation number
- 884.1050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- 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 |
|---|---|---|
| ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR (K974032) | A & A Medical, Inc. | 1997-12-22 |
| CERVICAL MUCOUS ASPIRATION CATHETER (K960263) | Cook Urological, Inc. | 1996-08-29 |
| SELECTMUCUS (K954102) | Select Medical Systems, Inc. | 1995-11-21 |
| ENDOCERVICAL ASPIRATOR (K902242) | Innovative Medical Products, Inc. | 1990-10-09 |
| O. B. PACK IV (K902032) | Customed, Inc. | 1990-09-28 |
| OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (K902954) | Permobil AB | 1990-08-23 |
| ASPIRETTE ENDOCERVICAL ASPIRATOR (K895403) | Unimar, Inc. | 1989-11-29 |
| DC PACK TM (K821134) | Seamless Hospital Products Co. | 1982-06-22 |
| ENDOCERVICAL ASPIRATOR (K812175) | Fertility Instrumentation, Inc. | 1981-09-21 |
| ACCU-PAP T ZONE SAMPLER (K801238) | Robert Hasselbrack, M.D. | 1980-08-12 |
Recalls involving this device
No recalls on record reference this clearance.