BOYLSTON SURGICAL LLC

FDA Device Registration & Listing · Osterville, MA, US · Registration 3033302333

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033302333
FEI Number
3033302333
Entity Name
BOYLSTON SURGICAL LLC
City/State/Country
Osterville, MA, US
Establishment Address
97 1st Ave, Osterville, MA 02655, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Boylston Surgical LLC (Owner Number: 10091794)
Owner / Operator Contact Address
97 1st Street, Osterville, MA 02655, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

X-RepairSL X-Repair

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-11-01
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2024-11-01
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-11-01
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2024-11-01

Official Correspondent

Kevin Seifert

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boylston Surgical LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033302333. Last updated year: 2026. Please use registration number 3033302333 when referencing this establishment in official correspondence.
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