CANNULA
FDA 510(k) clearance K843187 · decided 1984-10-31
Clearance details
- K-number
- K843187
- Device name
- CANNULA
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-13
- Decision date
- 1984-10-31
- Days to decision
- 79 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
- Somerville, NJ, 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 |
|---|---|---|
| MRI SAFE INSTRUMENTS (K003965) | Aesculap, Inc. | 2001-03-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |