ENDOPLUS
FDA 510(k) clearance K941969 · decided 1994-06-22
Clearance details
- K-number
- K941969
- Device name
- ENDOPLUS
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1994-04-22
- Decision date
- 1994-06-22
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sepang Selangor, MY
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wembley Rubber Products (M) Sdn Bhd
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.
Recalls involving this device
No recalls on record reference this clearance.