# K982646: Ailee Sutures and Ailee Needles

- Pathway: 510(k) (Traditional)
- Applicant: Myco Medical Supplies, Inc.
- Decided: Jun 2, 1999 after 308 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K180701: SafePath Suturing System (2018), 1 descendant of its own
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own
- K232355: Non absorbable Surgical Silk Suture (2024), 0 descendants of its own
- K212888: Golnit Nylon Monofilament Suture (2022), 0 descendants of its own

## Indications for use
Chromic Gut surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue. Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue. Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues. Silk sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.

Source page: https://510kreport.com/device/K982646
Methodology: https://510kreport.com/methodology