PDS Barbed Suture, PDO MAXX Threads

Suture, Surgical, Absorbable, Polydioxanone

PDO MAX, Inc.

The following data is part of a premarket notification filed by Pdo Max, Inc. with the FDA for Pds Barbed Suture, Pdo Maxx Threads.

Pre-market Notification Details

• Device ID: K190245
• 510k Number: K190245
• Device Name: PDS Barbed Suture, PDO MAXX Threads
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: PDO MAX, Inc. 4971 Bear Road Liverpool, NY 13088
• Contact: Giovanna Mccarthy
• Correspondent: Mary Vater; Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-06
• Decision Date: 2019-06-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850018324656	K190245	000
00850018324571	K190245	000
00850018324588	K190245	000
00850018324595	K190245	000
00850018324021	K190245	000
00850018324038	K190245	000
00850018324045	K190245	000
00850018324052	K190245	000
00850018324069	K190245	000
00850018324076	K190245	000
00850018324083	K190245	000
00850018324090	K190245	000
00850018324106	K190245	000
00850018324113	K190245	000
00850018324120	K190245	000
00850018324564	K190245	000
00850018324557	K190245	000
00850018324663	K190245	000
00850018324670	K190245	000
00850018324687	K190245	000
00850018324625	K190245	000
00850018324632	K190245	000
00850018324601	K190245	000
00850018324618	K190245	000
00850018324489	K190245	000
00850018324496	K190245	000
00850018324502	K190245	000
00850018324519	K190245	000
00850018324526	K190245	000
00850018324533	K190245	000
00850018324540	K190245	000
00850018324137	K190245	000
00850018324144	K190245	000
00850018324311	K190245	000
00850018324328	K190245	000
00850018324335	K190245	000
00850018324342	K190245	000
00850018324359	K190245	000
00850018324366	K190245	000
00850018324373	K190245	000
00850018324380	K190245	000
00850018324397	K190245	000
00850018324403	K190245	000
00850018324410	K190245	000
00850018324427	K190245	000
00850018324434	K190245	000
00850018324441	K190245	000
00850018324304	K190245	000
00850018324298	K190245	000
00850018324151	K190245	000
00850018324168	K190245	000
00850018324175	K190245	000
00850018324182	K190245	000
00850018324199	K190245	000
00850018324205	K190245	000
00850018324212	K190245	000
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00850018324243	K190245	000
00850018324250	K190245	000
00850018324267	K190245	000
00850018324274	K190245	000
00850018324281	K190245	000
00850018324458	K190245	000