FIXED-SIZE UTERINE DILATOR
FDA 510(k) clearance K890377 · decided 1989-02-13
Clearance details
- K-number
- K890377
- Device name
- FIXED-SIZE UTERINE DILATOR
- Applicant
- Kinetic Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1989-01-23
- Decision date
- 1989-02-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HDQ
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Erie, PA, 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 |
|---|---|---|
| CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (K930034) | Thomasville Medical Assoc. | 1994-02-24 |
| TEFLON CERVICAL ACCESS SET (K896701) | Cook Ob/Gyn | 1990-09-13 |
| CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (K891029) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| CERVICAL DILATOR (K811568) | Gynemetrics, Inc. | 1981-07-16 |
| MODEL 6500 EXTRACTION IRRIGATION SYS (K791277) | Cavitron Corp. | 1979-08-22 |
Recalls involving this device
No recalls on record reference this clearance.