STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
FDA 510(k) clearance K961524 · decided 1996-05-16
Clearance details
- K-number
- K961524
- Device name
- STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
- Applicant
- Sterilab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-22
- Decision date
- 1996-05-16
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HNY
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sterilab
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CYSTOTOMES/KNIFES (K880345) | Myocure, Inc. | 1988-05-03 |
| PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (K874976) | Advanced Surgical Products, Inc. | 1988-04-13 |
| PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (K874993) | Advanced Surgical Products, Inc. | 1988-04-13 |
| PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (K875001) | Advanced Surgical Products, Inc. | 1988-04-13 |
| PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (K874983) | Advanced Surgical Products, Inc. | 1988-04-13 |
| PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (K874997) | Advanced Surgical Products, Inc. | 1988-04-13 |
| PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (K874975) | Advanced Surgical Products, Inc. | 1988-04-13 |
| VAN DELLEN IRRIGATING CYSTOTOME (K873163) | Van Dellen, Ltd. | 1987-09-04 |
| CAPSULECTOMER CYSTOTOME (K871365) | Noetix, Inc. | 1987-04-16 |
| LOOK IRRIGATING CYSTOTOMES (K870439) | Look, Inc. | 1987-02-20 |
| MECHANICAL CYSTITOME (K862709) | Rudolph Beaver, Inc. | 1986-08-01 |
| PRECISION - COSMET CAPSULE COUPEUR (K852934) | Precision-Cosmet Co., Inc. | 1985-08-08 |
Recalls involving this device
No recalls on record reference this clearance.