# K213386: Titan Manufacturing Bipolar Forceps

- Pathway: 510(k) (Special)
- Applicant: Titan Manufacturing, Inc.
- Decided: Oct 25, 2021 after 12 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974593 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974593: Semkin Insulated Bipolar Forcep, Titan Mfg., Inc. (1998) Summary page 4.
- K974594: Semkin Bipolar Forcep, Titan Mfg., Inc. (1998) Summary page 4.
- K974595: Cushing Bayonet, Insulated Bipolar Forcep, Titan Mfg., Inc. (1998) Summary page 4.

## Most influential descendants
- K230432: Single Use Bipolar Forceps (2023), 0 descendants of its own

## Recalls of this device
- Nov 2, 2022 · Class II · Z-0373-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0375-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0376-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0377-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0379-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0385-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0387-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0389-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0390-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0392-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0394-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0397-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0400-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0401-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0402-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0403-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0404-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0405-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0410-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0374-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0378-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0380-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0381-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0382-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0383-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0384-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0386-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0388-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0391-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0393-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0395-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0396-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0398-2023: XXX
- Nov 2, 2022 · Class II · Z-0399-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0406-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0415-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0407-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0408-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0411-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0416-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0417-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0409-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0412-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0413-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d
- Nov 2, 2022 · Class II · Z-0414-2023: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the d

## Indications for use
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.

Source page: https://510kreport.com/device/K213386
Methodology: https://510kreport.com/methodology