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=K261543

Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.

Q: How to monitor Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. 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 Rhode Island records like this one.

Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. (Rhode Island): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. Its amount of 143 is above the median of 138 (53rd percentile). Dated 38 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 143 · 53th percentile of 414 FDAPulse records · 1.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 1 related RI FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K261543
Device	Phasix ST Parastomal Hernia Mesh
Applicant	Davol, Inc., A Subsidiary of C.R. Bard, Inc.
Specialty / panel	General, Plastic Surgery
Product code	OWT
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-05-08
Decision date	2026-09-28
Review time (days)	143
Third-party review	No
Applicant location	Warwick, RI, US
amount percentile	53th of 414 (median 138, 1.0x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-28
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. and 2 Rhode Island peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Rhode Island FDAPulse records like this one: 2
Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.'s amount: 53rd percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every Rhode Island peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 143-day review: this device is a strong predicate for similar products.
Posted 38 days ago.

What is the FDAPulse record for Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. in Rhode Island?

Phasix ST Parastomal Hernia Mesh (K261543) by Davol, Inc., A Subsidiary of C.R. Bard, Inc. was cleared on 2026-09-28 after 143 days of review.

How does Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. compare to other Rhode Island FDAPulse records?

Its amount of 143 sits in the upper half (53th percentile) of 414 records; the median is 138. It is 38 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.

Phasix ST Parastomal Hernia Mesh (K261543) vs. top 3 peers

Organization	Location	Record date
Phasix ST Parastomal Hernia Mesh (K261543)	RI	2026-09-28
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 Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. and peer general & plastic surgery records

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