Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
FDA 510(k) clearance K153611 · decided 2016-06-03
Clearance details
- K-number
- K153611
- Device name
- Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
- Applicant
- Ethicon, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-12-17
- Decision date
- 2016-06-03
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Los Frailes Industrial Park, Suite 401, PR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ethicon
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.