Picocyl

FDA Device Registration & Listing · Golden, CO, US · Registration 3043531632

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
3043531632
FEI Number
3043531632
Entity Name
Picocyl
City/State/Country
Golden, CO, US
Establishment Address
221 Corporate Cir Ste L, Golden, CO 80401, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PICOCYL (Owner Number: 10085594)
Owner / Operator Contact Address
150 CAPITAL DRIVE, STE. 470, Golden, CO 80401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Injection Kit Self Administration Support Kit Apellis Injection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2024-12-19
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-12-19
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2025-07-21
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2022-12-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-12-09

Official Correspondent

Gary Holland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015176914 PICOCYL Golden, CO, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043531632. Last updated year: 2026. Please use registration number 3043531632 when referencing this establishment in official correspondence.
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