Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip
FDA 510(k) K140343 · Aesculap, Inc.
510(k) numberK140343
Submission
- Device name
- Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- February 11, 2014
- Decision date
- May 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPN – Tissue Adhesive For The Topical Approximation Of Skin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4010
- Specialty
- General, Plastic Surgery
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Other 510(k)s with product code MPN
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|---|---|---|---|
| K243990 | BondEase 2 Topical Skin AdhesiveMPN · Traditional | Optmed, Inc. | 09/19/2025SE |
| K250950 | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)MPN · Traditional | Okapi Medical, LLC Dba Resivant Medical | 08/04/2025SE |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)MPN · Traditional | Okapi Medical, LLC Dba Resivant Medical | 08/20/2024SE |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004)MPN · Traditional | Connexicon Medical , Ltd. | 07/15/2024SE |
| K230981 | Meriglu Topical Skin AdhesiveMPN · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/16/2024SE |
| K212246 | Exofin Precision PenMPN · Special | Chemence Medical, Inc. | 09/09/2021SE |
| K200264 | Exofin High Viscosity Topical Skin AdhesiveMPN · Traditional | Chemence Medical, Inc. | 12/17/2020SE |
| K183570 | LiquiBand PlusMPN · Traditional | Advanced Medical Solutions Limited | 03/09/2020SE |
| K162352 | derma+flex QS High Viscosity Tissue AdhesiveMPN · Traditional | Chemence Medical, Inc. | 12/22/2016SE |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist…MPN · Traditional | Adhezion Biomedical, LLC | 11/08/2016SE |
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Questions and answers
When was Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip cleared by the FDA?
Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip (K140343) received a 510(k) decision of Substantially Equivalent on May 13, 2014, 91 days after the submission was received.
What is the product code of K140343?
The FDA product code is MPN – Tissue Adhesive For The Topical Approximation Of Skin, a Class II (moderate risk) device regulated under 21 CFR 878.4010.