Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263073

Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC

Q: How to monitor Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC and peer general & plastic surgery records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow Oregon records like this one.

Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC (Oregon): 510(k) cleared for Riverpoint Medical, LLC. Its amount of 28 is below the median of 138 (6th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median

Free preview: all 14 published fields of this record are shown below. Locked: 0 related OR FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K263073
Device	Fast Absorbing PGLA
Applicant	Riverpoint Medical, LLC
Specialty / panel	General, Plastic Surgery
Product code	GAM
Device class	2
Clearance type	Special
Decision	Substantially Equivalent
Received	2026-09-01
Decision date	2026-09-29
Review time (days)	28
Third-party review	No
Applicant location	Portland, OR, US
amount percentile	6th of 414 (median 138, 0.2x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-29
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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41 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 28-day review: this device is a strong predicate for similar products.
Special 510(k): a modification of an existing device.
Posted 36 days ago.

What is the FDAPulse record for Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC in Oregon?

Fast Absorbing PGLA (K263073) by Riverpoint Medical, LLC was cleared on 2026-09-29 after 28 days of review.

How does Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC compare to other Oregon FDAPulse records?

Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 36 days old, still within a typical 45-day follow-up window.

Fast Absorbing PGLA (K263073) vs. top 3 peers

Organization	Location	Record date
Fast Absorbing PGLA (K263073)	OR	2026-09-29
TECAR Therapy Device (TC2000, TC2001) (K252288)	CN	2026-10-13
easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291)	CN	2026-09-25
PicoreMax (PicoreMax) (K254199)	KR	2026-09-24

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How to monitor Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC and peer general & plastic surgery records

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