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510(k) clearances

Fast Absorbing PGLA

Riverpoint Medical, LLC · General, Plastic Surgery

K263073Substantially EquivalentSpecialGAM
Open FDA's page for this record
Third party flag
N
City
Portland
Advisory committee description
General, Plastic Surgery
Address 1
825 NE 25th Ave.
Statement or summary
Summary
Product code
GAM
Zip code
97232
Applicant
Riverpoint Medical, LLC
Decision date
2026-09-29
Decision code
SESE
Country code
US
Device name
Fast Absorbing PGLA
Advisory committee
SU
Contact
Rose Nakaweesi
K number
K263073
State
OR
Date received
2026-09-01
Review advisory committee
SU
Postal code
97232
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Medical specialty description
General, Plastic Surgery
Regulation number
878.4493
Device class
2
Registration number
3030733800, 3009380063, 3007205024, 1066741, 2020601, 3010041511, 3030446844, 3004117249, 2650143, 3010864832, 3013644499, 2030624, 3008114965, 3005953126, 3004215117, 2210968, 3014579161, 3008868758, 9681572, 3024021261, 3016904853, 3018064853, 3013557562, 3010860245, 3043226252, 3011137372, 3013176080, 3038718579, 9680794, 3010131137, 1054241, 3017102971, 1219930, 3008912461, 3044819802, 1221934, 3001124136, 3019924, 3006680097, 3007006186 +106 more
FEI number
3030733800, 3009380063, 3007205024, 2020601, 3010041511, 3030446844, 1000512168, 3004117249, 3013644499, 3008114965, 3002902735, 3005953126, 3004215117, 2210968, 3014579161, 3008868758, 3024021261, 3016904853, 1000136478, 3018064853, 3013557562, 3010860245, 3043226252, 3013176080, 3038718579, 3010131137, 3017102971, 1219930, 3008912461, 3044819802, 1000112968, 1221934, 3001124136, 3005747797, 3019924, 3006680097, 3007006186, 3003828812, 3029901632, 1720929 +106 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.