LAPAROMED LIGATING LOOP
FDA 510(k) clearance K921053 · decided 1992-08-06
Clearance details
- K-number
- K921053
- Device name
- LAPAROMED LIGATING LOOP
- Applicant
- Laparomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-05
- Decision date
- 1992-08-06
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- KCJ
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Laparomed Corp.
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 |
|---|---|---|
| ENDOPATH TISSUE RETAINING COMPONENT (K923679) | Ethicon Endo-Surgery, Inc. | 1992-09-09 |
| APDYNE PHENOL APPLICATOR KIT (K894369) | Apdyne Medical Co. | 1989-10-12 |
| LUCAE'S EAR & NASAL APPLICATORS (K832667) | Kells Medical, Inc. | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.