ETHICON LACRIMAL STENT
FDA 510(k) clearance K812255 · decided 1981-08-20
Clearance details
- K-number
- K812255
- Device name
- ETHICON LACRIMAL STENT
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-12
- Decision date
- 1981-08-20
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- HNL
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, 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 |
|---|---|---|
| CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491) | Concept, Inc. | 1984-10-05 |
| TSE-ANDERSON MODIFIED LACRIMAL GROOV (K840861) | Hansen Ophthalmic Development Lab | 1984-05-09 |
| STERILE OIL AND GUIDEWIRE (K833671) | CooperVision, Inc. | 1984-01-10 |
| LACIMAL INTUBATION SETS (K831901) | Visitec Co. | 1983-07-12 |
| PILLING LACRIMAL INTUBATION SYSTEM (K813187) | Narco Scientific | 1982-01-28 |
| CONCEPT CANALICULUS INTUBATION SET (K802845) | Concept, Inc. | 1980-12-17 |
| JACKSON LACRIMAL INTUBATION SET (K801232) | Storz Instrument Co. | 1980-06-17 |
| CRAWFORD LACRIMAL INTUBATION SET (K800089) | Jedmed Instrument Co. | 1980-03-03 |
| NASO-LACRIMAL DUCT INSERT (K770194) | Concept, Inc. | 1977-02-14 |
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 |