RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
FDA 510(k) clearance K893741 · decided 1989-08-17
Clearance details
- K-number
- K893741
- Device name
- RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-05-17
- Decision date
- 1989-08-17
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GCX
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Abbott Park, 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 |
|---|---|---|
| STRYKER CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |
| CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126) | Circon Corp. | 1999-08-03 |
| SUCTION INSTRUMENTATION (K972074) | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |
| MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127) | Allegiance Healthcare Corp. | 1996-12-31 |
| CURITY THORACENTESIS TRAY (K964519) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| STRYKER SUCTION REGULATOR (K963648) | Stryker Endoscopy | 1996-11-26 |
| RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920) | R&S Surgical, LLC | 1996-10-21 |
| MEDCARE SUCTION CONNECTING TUBING (K961880) | Medcare Medical Group, Inc. | 1996-07-19 |
| CPR YANKAUER (K960223) | Custom Pack Reliability | 1996-03-28 |
| MEDCARE YANKAUER SUCTION DEVICE (K954869) | Medcare Custom Packaging, Inc. | 1996-01-19 |
| STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726) | Stryker Endoscopy | 1995-11-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032) | Abbott Laboratories | 2026-05-11 |
| ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068) | Abbott Laboratories | 2026-02-23 |
| ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |