MRI SAFE INSTRUMENTS
FDA 510(k) clearance K003965 · decided 2001-03-16
Clearance details
- K-number
- K003965
- Device name
- MRI SAFE INSTRUMENTS
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-22
- Decision date
- 2001-03-16
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- GEA
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Allentown, 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 |
|---|---|---|
| GENICON TROCAR (K982472) | Genicon, LC | 1999-02-04 |
| CONMED TROGARD ELECTRONIC TROCAR SYSTEM (K954599) | Conmedcorp | 1995-11-27 |
| ORIGIN SECONDARY CANNULA AND TROCAR (K922460) | Origin Medsystems, Inc. | 1992-09-16 |
| ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (K920110) | ETHICON, Inc. | 1992-04-02 |
| DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (K911262) | ETHICON, Inc. | 1991-06-20 |
| DISPOSABLE YANKAUER SUCTION TUBE (K904881) | Pilling Medical S.A. | 1991-03-06 |
| CANNULA, SURGICAL (K903416) | Advantage Diagnostics Corp. | 1990-11-23 |
| SUCTION SYSTEM (K904218) | Axiom Medical, Inc. | 1990-10-31 |
| KLEIN MICRO-CANNULA(TM) (K901717) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| KLEIN LAMPREY-CANNULA(TM) (K901718) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| KLEIN MICRO-CANNULA HANDLE(TM) (K901719) | Jeff Klein Surgical, Inc. | 1990-05-22 |
| SOFT SUCTION ADAPTER (K895684) | Applied Medical Technologies | 1989-11-20 |
Recalls involving this device
No recalls on record reference this clearance.