Dexon Dissecting Sponge

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K914365 ↗

FDA Product Code

GAK

Device Class

Class II

Regulation

21 CFR Part 878.4830

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Davis & Geck, Inc. →

• What is the Dexon Dissecting Sponge used for in surgical procedures?

  The Dexon Dissecting Sponge is designed specifically for plastic surgery procedures to facilitate tissue dissection and manipulation. Its absorbable material allows for gentle yet effective separation of tissues without causing excessive trauma, making it ideal for delicate surgical interventions where precision is critical.

• Is the Dexon Dissecting Sponge intended for single-use or reuse?

  The Dexon Dissecting Sponge is supplied as a single-use item. This ensures sterility and reduces the risk of cross-contamination, which is essential in sterile surgical settings where infection control is paramount.

• What regulatory clearance does the Dexon Dissecting Sponge hold?

  The Dexon Dissecting Sponge holds FDA clearance under the Traditional 510(k) pathway, with a clearance number of K914365. It was granted substantial equivalence in 1991 for use in general and plastic surgery applications, adhering to FDA standards for absorbable surgical materials.

• How is the Dexon Dissecting Sponge classified under FDA regulations?

  The Dexon Dissecting Sponge is classified as a Class II device under FDA regulations, specifically under product code GAK. This classification reflects its role as an absorbable suture-related device, requiring additional controls to ensure safety and effectiveness in surgical applications.

• What type of surgical setting is the Dexon Dissecting Sponge intended for?

  The Dexon Dissecting Sponge is intended exclusively for sterile surgical settings. Its absorbable nature and design make it suitable for procedures where maintaining a sterile field is critical, such as plastic surgery, to minimize infection risks and ensure optimal surgical outcomes.