SER-TEX
FDA 510(k) clearance K800834 · decided 1980-06-30
Clearance details
- K-number
- K800834
- Device name
- SER-TEX
- Applicant
- V.S.S.I., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-14
- Decision date
- 1980-06-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KOH
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| KSEA CHARDONNES MORCELLATION KNIFE (K000212) | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 |
| C-SECTION PACK (K921730) | Medikmark, Inc. | 1994-06-15 |
| MINOR LAP SET (K921732) | Medikmark, Inc. | 1994-06-15 |
| NEWPORT LATERAL VAGINAL RETRACTOR (K891351) | Simpson/Basye, Inc. | 1989-05-11 |
| VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (K892693) | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| NEEDLE EXTENSIONS (K891035) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| ZEPPELIN SCISSORS (K891049) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (K863610) | Ob/Gyn Concepts, Ltd. | 1987-01-07 |
| CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (K840308) | Imm Enterprises , Ltd. | 1984-03-05 |
| QUARTZ RETRACTOR/PROBE (K823792) | American V. Mueller | 1983-01-18 |
| UTERINE MANIPULATORS (K812204) | Reznik Instruments | 1981-10-13 |
| VAGI-PRESS #401 (K790851) | C. Intl. | 1979-07-30 |
Recalls involving this device
No recalls on record reference this clearance.