# K012201: Premicron Nonabsorbable Pet Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Sep 19, 2001 after 68 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SURGIDAC® Nonabsorbable Surgical Suture (U. S. Surgical Corp.): named in the summary without a submission number
- (no number) ETHIBOND® Nonabsorbable Surgical Suture (Ethicon, Inc.): named in the summary without a submission number
- (no number) TI-CRON® Nonabsorbable Surgical Suture (Sherwood Davis & Geck): named in the summary without a submission number
- (no number) Synthofil® Nonabsorbable Surgical Suture (AESCULAP®): named in the summary without a submission number

## Most influential descendants
- K133890: Aesculap Optilene Nonabsorbable Suture (2014), 5 descendants of its own
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (2016), 3 descendants of its own
- K192420: Crownjun Nylon Suture (2020), 1 descendant of its own
- K221280: Vesseal (2022), 0 descendants of its own
- K212603: Non Absorbable Surgical Nylon Suture (2021), 0 descendants of its own

## Indications for use
PremiCron® Nonabsorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K012201
Methodology: https://510kreport.com/methodology