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- Surgical Sutures - Performance Criteria for Safety and . . .
The surgical sutures that are the subject of this guidance are absorbable and nonabsorbable sutures under the following regulations and product codes outlined in Table 1 These devices are
- FDA Announces Optional Pathway for Clearance of Surgical . . .
In fact, our internal teams of medical device development experts communicate with the FDA nearly every day From Pre-Submission meetings, to Pre-IDE preparation and FDA inspection preparation and SAMD AI ML reviews, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers
- Is Catgut Really Obsolete? Experience with Buried . . .
A good scar after surgery is desirable Skin closure with subcuticular sutures is known to give better scars Absorbable sutures reduce suture track infection Catgut is a monofilament absorbable suture, which has not been generally recommended for
- Chromic Catgut Sutures: Different Sizes, Indication, and . . .
Surgical sutures can be plain or chromic Chromic catgut sutures are absorbable sterile surgical sutures made by twisting together strands of purified connective tissue (mostly collagen), derived from the serosal layer of bovine intestines (sheep and goat) They have twisted multifilament structure with a monofilament appearance
- Summary of Safety Effectiveness - Food and Drug Administration
o T Cad International, Plain Chromic Catgut Suture, Trading Consultants Distributors International Inc 510K Number K994002, Chicago IL o CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, 510K Number K001299, CP Medical Portland Oregon F Device Description: Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile
- Absorbable Gut Suture, Catgut Sutures - MSEC
Without the need for physical removal the catgut can be used in internal tissues and internal organs without either leaving material in the body or requiring additional procedures for removal The one drawback to catgut sutures is that there is not a define degradation time; rather it is more of a generalized time frame or reference point
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