KSEA CHARDONNES MORCELLATION KNIFE
FDA 510(k) clearance K000212 · decided 2000-04-21
Clearance details
- K-number
- K000212
- Device name
- KSEA CHARDONNES MORCELLATION KNIFE
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-24
- Decision date
- 2000-04-21
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KOH
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Culver City, CA, 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 |
|---|---|---|
| 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 |
| SER-TEX (K800834) | V.S.S.I., Inc. | 1980-06-30 |
| VAGI-PRESS #401 (K790851) | C. Intl. | 1979-07-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |