# K834403: Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bobbs Medical, Inc.
- Decided: Feb 4, 1984 after 52 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 4, 2024 · Class II · Z-0469-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0468-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0476-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0470-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0471-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0472-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0473-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0474-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Oct 4, 2024 · Class II · Z-0475-2025: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocke
- Jul 29, 2022 · Class II · Z-0020-2023: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-1
- Jul 29, 2022 · Class II · Z-0021-2023: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-1
- Jul 29, 2022 · Class II · Z-0032-2023: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-1

Source page: https://510kreport.com/device/K834403
Methodology: https://510kreport.com/methodology