Name: Predicase
Price: 199 USD

K-number	K101444
Device name	AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
Applicant	Surgical Devices, A Global Business Unit Tyco
Product code	GDW
Device class	Class II
Decision date	Jun 14, 2010
Decision	Substantially Equivalent
Regulation	878.4750

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY

Everything you need for a 510(k) submission. Nothing you don't.