Popper & Sons, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Popper & Sons, Inc. makes
Popper & Sons, Inc. manufactures a range of biopsy and aspiration needles, including the Jamshidi Type-Bone Marrow Biopsy/Aspiration Needle, Illinois Sternum/Iliac Aspiration Needle, and various biopsy-specific needles like the Bierman, Westerman-Jensen, Gardner, Antrum-Wolf, and Wescott types. The portfolio also includes single-lumen hypodermic needles designed for medical aspiration procedures.
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
J -Jamshidi Type-Bone Marrow Biopsy/Aspi Ref K843830
Regimes: 510(k) Registry: 510(k)Illinois Sternum/Iliac Aspiration Needle Ref K843690
Regimes: 510(k) Registry: 510(k)Hypodermic Needles, Single Lumen Ref K911397
Regimes: 510(k) Registry: 510(k)Bierman Biopsy Needle Ref K841299
Regimes: 510(k) Registry: 510(k)Westerman-Jensen Biopsy Needle Ref K840168
Regimes: 510(k) Registry: 510(k)Gardner Type Bone Marrow Needle Ref K841301
Regimes: 510(k) Registry: 510(k)Antrum Needle-Wolf Type Ref K841300
Regimes: 510(k) Registry: 510(k)Wescott Type Biopsy Needle Ref K842406
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Popper & Sons, Inc., initiated on 2008-01-02. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 2 Jan 2008 Z-0881-2008 Unclassified (pre-2012) Terminated Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.
Frequently asked questions
How many devices does Popper & Sons, Inc. have in the registry?
The registry currently lists 8 devices for Popper & Sons, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Popper & Sons, Inc.'s devices?
Among its 8 most recently registered devices, Popper & Sons, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Popper & Sons, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Popper & Sons, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Popper & Sons, Inc.?
FDA recall records list 1 recall initiated by Popper & Sons, Inc., the most recent initiated on 2 Jan 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Popper & Sons, Inc. in the registry?
The most recently registered devices listed for Popper & Sons, Inc. include J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI, ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE, HYPODERMIC NEEDLES, SINGLE LUMEN and BIERMAN BIOPSY NEEDLE.