MINICLAMPS, STABILIZ., FALLOPIAN TUBE
FDA 510(k) clearance K772229 · decided 1978-01-03
Clearance details
- K-number
- K772229
- Device name
- MINICLAMPS, STABILIZ., FALLOPIAN TUBE
- Applicant
- J. Sklar Mfg. Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-06
- Decision date
- 1978-01-03
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HCZ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fetzer Medical Gynecological Forceps (K172661) | Fetzer Medical GmbH & Co. KG | 2018-05-08 |
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| INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (K092840) | Instrumed International, Inc. | 2009-12-03 |
| FORCEPS, SURGICAL GYNECOLOGICAL (K944055) | Owens Precision Systems, Inc. | 1994-09-20 |
| PEARL PACKING FORCEPS (K941528) | Cook Urological, Inc. | 1994-05-12 |
| CORSON MYOMA GRASPING FORCEPS (K926484) | Thomasville Medical Assoc. | 1994-02-25 |
| Z-CLAMP FORCEPS (K926533) | Thomasville Medical Assoc. | 1994-02-25 |
| HYSTERECTOMY FORCEPS (K926531) | Thomasville Medical Assoc. | 1994-02-25 |
| VARIOUS FORCEPS (K930799) | Thomasville Medical Assoc. | 1994-02-24 |
| OVUM FORCEPS (K926528) | Thomasville Medical Assoc. | 1994-02-24 |
| FORCEPS: MCGRAVEY, MCINDOE, GILLIS (K930039) | Thomasville Medical Assoc. | 1994-02-24 |
| LAPAROSCOPIC FORCEPS (K911474) | United States Endoscopy Group, Inc. | 1991-07-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/ recall (Z-0939-2025) | Sklar Instruments | 2025-01-16 |
| ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 recall (Z-0943-2025) | Sklar Instruments | 2025-01-16 |
| ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM ST recall (Z-0946-2025) | Sklar Instruments | 2025-01-16 |
| ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STE recall (Z-0947-2025) | Sklar Instruments | 2025-01-16 |
| ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"C recall (Z-0948-2025) | Sklar Instruments | 2025-01-16 |