# K972245: Tom Cat F.L., Tom Cat S.L.

- Pathway: 510(k) (Traditional)
- Applicant: A & A Medical, Inc.
- Decided: Aug 6, 1997 after 51 days
- Product code: MFD (Cannula, Intrauterine Insemination)
- Device class: 2
- Regulation: 21 CFR 884.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Malkler Insemination Device: named in the summary without a submission number
- (no number) CSI Insemination Instrument and Sheath: named in the summary without a submission number
- (no number) Oligospermis Cup: named in the summary without a submission number
- (no number) Cervical Cap: named in the summary without a submission number
- (no number) Seminor: named in the summary without a submission number
- (no number) Uni-Sem: named in the summary without a submission number
- (no number) Jansen-Anderson Insemination Set: named in the summary without a submission number
- (no number) Lifetek IUI Catheter: named in the summary without a submission number
- (no number) Insemi-Cath: named in the summary without a submission number
- (no number) Select IUI: named in the summary without a submission number
- (no number) Insemi-Cath II: named in the summary without a submission number
- (no number) Genxcatheter: named in the summary without a submission number
- (no number) Wallace Artificial Insemination catheter- 8CM/18C M: named in the summary without a submission number
- (no number) Intrauterine Insemination Catheter: named in the summary without a submission number
- (no number) Insemi-Cath Insemination catheter: named in the summary without a submission number
- (no number) Edwards-Wallace Bourne-Hall: named in the summary without a submission number
- (no number) Intrauterine Insemination and Sonohysterography catheter: named in the summary without a submission number
- (no number) Resubmitted Artificial Insemination Instrument set: named in the summary without a submission number
- (no number) Shepard Intrauterine Insemination catheter: named in the summary without a submission number
- (no number) Minispace IUI Catheter: named in the summary without a submission number

## Most influential descendants
- K984306: `the Inseminator' (Proposed) (1999), 0 descendants of its own

## Indications for use
The TomCat Intrauterine Insemination Catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter can handle washed sperm to be delivered into the uterine cavity. This device is not intended for assisted reproduction procedures.

Source page: https://510kreport.com/device/K972245
Methodology: https://510kreport.com/methodology